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The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline.
Facing financial challenges, IN8bio is looking to preserve cash resources through a pipeline prioritization and layoffs at its New York City and Birmingham, Alabama, sites.
In its legal complaint, filed in the District Court for New Jersey, Regeneron alleges that Sandoz failed to provide it with relevant information required under the Biologics Price Competition and Innovation Act.
Quotient Therapeutics’ platform targets somatic mutations, which the startup contends can help identify a broader scope of genes potentially associated with disease phenotypes. Wednesday’s agreement is part of an existing partnership between Pfizer and Flagship Pioneering.
The company joins Eli Lilly in offering its own digital platform to more directly connect to patients, allowing them easier access to healthcare providers and prescription drugs.
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
The regulator’s Complete Response Letter flagged problems at a third-party fill/finish site, which Regeneron says it has already addressed. The manufacturing facility is currently awaiting reinspection.
SIGA Technologies’ TPOXX did not outperform placebo at resolving lesions in patients with clade I mpox, the new strain that has spread through parts of Africa and is reaching beyond the continent.
Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval.
The entry of new players and new approaches into the ATTR-CM space could help bring down the cost of treatment, experts say.
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